CS-206 in Patients With Sickle Cell Disease
The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 injection in treating sickle cell disease.
| Condition(s) | Sickle Cell Disease |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 injection in treating sickle cell disease. |
| Who can participate | Inclusion Criteria: * Participants must be between 12 to 35 years old (inclusive). Participants or their legal guardians (for participants below 18 years old) must provide written informed consent before any study-related procedures. * Participants must have a Documented βS/βS, βS/β0 or βS/β+ genotype. * Participants must have at least one of the following conditions 1. At least 2 occurrences of any of the following events within 2 years prior to screening. 1. Acute pain crisis: requiring a visit to a medical facility and administration of pain medications (opioids or intravenous NSAIDs) or red blood cell transfusions. 2. Acute chest syndrome: defined by the presence of a new pulmonary infiltrate on a chest X-ray, associated with pneumonia-like symptoms, including chest pain, fever, or res |
| Ages | 12 Years to 35 Years |
| Sex | All |
| Lead sponsor | CorrectSequence Therapeutics Co., Ltd |
| Locations | Nanning, Guangxi, China |
| Start date | 2024-09-02 |
| NCT ID | NCT06565026 |
| Official listing | https://clinicaltrials.gov/study/NCT06565026 |